Cutaneous LeishmaniasesPhase 3NCT04515186
Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World
A Phase 3 study testing Meglumine Antimoniate, Miltefosine and Thermotherapy machine in people with Cutaneous Leishmaniases, run by Drugs for Neglected Diseases at 6 sites in 4 countries.
Trial summary
This study evaluates if the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine is safe and have a comparable cure rate with the current recommended first line treatments comprising meglumine antimoniate for 3 weeks for the treatment of uncomplicated cutaneous leishmaniasis cases in… Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Cutaneous Leishmaniases
- What is being tested?
- Meglumine Antimoniate, Miltefosine and Thermotherapy machine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 26 Jan 2021to 27 Feb 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females, aged ≥12 and ≤60 years old (upper age limit according to local regulations), and weighing ≥ 30Kg.
- Patient with a confirmed diagnosis of CL in at least one lesion by at least one of the following methods: 1) microscopic identification of amastigotes in stained lesion tissue, or 2) demonstration of Leishmania by Polymerase Chain Reaction (PCR), or 3) positive culture for promastigotes.
- Patient has a lesion that satisfies the following criteria:
- Lesion size ≥ 0.5 cm and ≤ 4 cm (longest diameter).
- not located on the ear, face, close to mucosal membranes, or on a location that in the opinion of the Principal Investigator (PI) is difficult to apply the TT.
- Patient with ≤ 4 CL lesions.
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- Duration of lesion less than 4 months by patient history.
- Patient able to give written informed consent/ assent form.
- In the opinion of the investigator, the patient is capable of understanding and complying with the protocol.
Who cannot join
- Female with a positive urine or blood pregnancy test at screening or who is breast feeding or female at fertile age who does not agree to take appropriate effective contraception during treatment period and up to D180 visit. In Brazil: female at fertile age who does not agree to use two effective methods of contraception: one barrier method and one highly effective method (defined in section 8.2.4) 30 days prior to the treatment onset and up to D180 visit.
- History of clinically significant medical problems / treatment that might interact, either negatively or positively, with treatment of cutaneous leishmaniasis including any immunocompromising condition.
- Within 8 weeks (56 days) of Day 1, received treatment for the entry lesion leishmaniasis with any medication including antimonials likely, in the opinion of the PI, to modify the course of the Leishmania infection.
- Has diagnosis or suspected diagnosis of mucocutaneous leishmaniasis based on physical exam.
- Has laboratory values at screening as follows:
- Serum creatinine: above upper normal level*.
Show all 12Show fewer
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST): 3 times above upper normal level*.
- Normal ranges obtained from local laboratory.
- Patient who is not willing to attend the study visits or is not able to comply with follow-up visits up to 6 months.
- Known history of addiction/ alcohol abuse.
- Hypersensitivity to miltefosine or any study medication excipients.
- Patients with Sjogren-Larson Syndrome.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Brazil3 sites
Instituto René Rachou Oswaldo Cruz Foundation- FIOCRUZ MINAS
Belo Horizonte, Minas Gerais
Julio Muller University Hospital Federal University of Mato Grosso
Cuiabá
Federal University of Bahia Immunology Department
Salvador
Panama1 site
Instituto Conmemorativo Gorgas de Estudios de la Salud
Panama City, Provincia de Panamá
About this study
Official title: Efficacy and Safety of Thermotherapy in Combination With Miltefosine Compared Iltefosine Monotherapy for the Treatment of New World Cutaneous Leishmaniasis: A Phase III, Open Label, Multicenter Randomized Trial
This study evaluates if the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine is safe and have a comparable cure rate with the current recommended first line treatments comprising meglumine antimoniate for 3 weeks for the treatment of uncomplicated cutaneous leishmaniasis cases in the New World.
Read the detailed description
This randomized, open label, multi-centre, non-inferiority study aims to compare that the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine (2.5 mg/kg/day for 21 days orally) (here after referred to as combination), is non-inferior to the current recommended first line treatment miltefosine monotherapy (2.5 mg/kg/day for 28 days orally), for uncomplicated CL cases in the New World.
Originally, the study was planned to assess the non-inferiority of the combination therapy in comparison to the current recommended first line treatments, meglumine antimoniate or miltefosine monotherapy for 28 days. However, based on the revised treatment guidelines published by WHO-PAHO in 2022 in which the use of systemic antimonial received only a conditional recommendation, principally because of its well-known toxicity, and is recommended to be used only in case where there is no other option, the study protocol amendment 7 was proposed to prematurely discontinue the inclusion of additional patients in the meglumine antimoniate arm.
Primary Objective
- To determine the non-inferior efficacy of the combination in comparison to the standard first line treatment miltefosine monotherapy as measured by the percentage of patients with initial clinical cure at Day 90.
Secondary objectives
- Assess the proportion of patients who show clinical improvement at D90 (have more or equal of 75% and less than 100% re-epithelization) and achieve 100% re-epithelization at D105 (late responders).
- Assess the proportion of relapses at D180.
- Describe the proportion of patients randomized in the meglumine antimoniate arm until its discontinuation who show initial cure at D90, clinical improvement at D90 and 100% re-epithelization at D105 and relapse at D180.
- Assess the safety and tolerability profile for each regimen (percentage of treatment discontinuation, frequency and severity, causality with each study drug and seriousness of Adverse Events (AEs)).
- Assess the time to achieve 100% re-epithelialization/ flattening of ulcerated/ non ulcerated lesions by Leishmania species.
A computer-generated randomization code will be used for patient treatment allocation to one of the three arms indicated and utilizing a 1:1:1 allocation ratio.
Patients assigned to the combination treatment will start treatment at Day 1 and have a follow-up visit on 24 hours to assess safety of thermotherapy. Hereafter, these patients are required to return at Days 7, 14, 21, 45, 63, 90, 105 (late responders only) and 180 after the beginning of treatment to assess safety and efficacy.In Brazil, women of childbearing potential are required to also return on D120 and D150 to perform blood pregnancy tests. Women with irregular menstrual cycle, should return for blood pregnancy tests every two weeks until D150.
Patients assigned to the meglumine antimoniate treatment before discontinuation of this arm becomes effective arerequired to come at Days 1, 7, 14, 21, 45, 63, 90, 105 (late responders only) and 180 after the beginning of treatment to assess safety and efficacy.
Patients assigned to the miltefosine monotherapy are required to come at Days 1, 7, 14, 21, 28, 45, 63, 90, 105 (late responders only) and 180 after the beginning of treatment to assess safety and efficacy. In Brazil, women of childbearing potential are required to also return on D120 and D150 to perform blood pregnancy tests. Women with irregular menstrual cycle, should return for blood pregnancy tests every two weeks until D150.
Patients who have 100% re-epithelization at D90 are declared cured and appointed to come to their D180 assessment. If at D90 re-epithelization of the ulcer(s) is more or equal to 75% but less than 100%, patients will be defined as having clinical improvement and will be asked to return to D105 for a late responder assessment.
- Conditions
- Cutaneous Leishmaniases
- Being tested
- Meglumine Antimoniate, Miltefosine, Thermotherapy machine
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meglumine AntimoniateDrug
Also called Glucantime®
Vials of a 5mL solution. Each vial contains 405 mg of Sb5+ corresponding to 8.1% Sb5+ (81 mg/mL).
MiltefosineDrug
Also called Impavido®
50 mg capsule
Thermotherapy machineDevice
Also called ThermoMed™
Localized Current Field radio-frequency generating device
| Study group | Role | What they receive |
|---|---|---|
| Meglumine Antimoniate | Other | Meglumine Antimoniate, 20 mg/kg/day for 20 days parenterally. This trial arm was discontinued after protocol amendment 7. However, patients assigned to this arm before protocol amendment 7 becomes effective will continue in the study and will receive complete treatment as initially planned. Receives: Drug: Meglumine Antimoniate |
| Miltefosine monotherapy | Active comparator | Miltefosine monotherapy 2.5 mg/kg/day for 28 days orally Receives: Drug: Miltefosine |
| Thermotherapy + miltefosine | Experimental | Thermotherapy (one session, 50⁰C for 30" applications*) + miltefosine 2.5 mg/kg/day for 21 days orally. Receives: Drug: Miltefosine; Device: Thermotherapy machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of initial clinical cure in each arm.
Defined for ulcerated lesions as 100% re-epithelialization of the ulcer(s) on D90 as compared to D1 and for non-ulcerated lesions as flattening and/or no signs of induration of the lesion(s) on D90 as compared to D1.
Measured: Day 90
Secondary outcomes (5)
The number of patients who fulfil the criteria for clinical improvement at D90 and late responders at D105.
Clinical improvement is defined for ulcerated lesions as more than or equal to 75% but less than 100% re-epithelization of the ulcer(s) as compared to D1, and for non-ulcerated lesions as more than or equal to 75% but less than 100% of flattening and/ or signs of induration of the lesion(s) as compared to D1.
Late responders isdefined for ulcerated lesions as 100% re-epithelialization of the ulcer(s) on D105 compared to D1, and for non-ulcerated lesions as 100% of flattening and/or no signs of induration of the lesion(s) on D105 as compared to D1.
Measured: Days 90 and 105
The number of patients who fulfil the criteria of initial cure at D90 or late responders at D105 and have no relapse by D180 (final cure).
Measured: Day 180
Percentage of treatment discontinuation, frequency, severity, causality with each study drug and seriousness of AEs by treatment group.
Measured: Through study completion, i.e up to 6 months
Proportion of lesions with 100% re-epithelialization/flattening at each measurement time point by Leishmania sp.
Measured: Days 7, 14 and 21. At end of treatment (days 21 or 28), and at days 45, 63, 90, 105 and 180.
The number of patients randomized in the meglumine antimoniate arm until its discontinuation who fulfill the criteria of initial cure at D90 or late responders at D105 and have no relapse by D180 (final cure).
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start26 Jan 2021
- Primary completion10 Nov 2023
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LeishmaniasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulo Machado, Principal investigator, Federal University of BahiaMarcia Hueb, Principal investigator, Julio Muller University Hospital Federal University of Mato GrossoFiorela Yuly Alvarez Romero, Principal investigator, Universidad Peruana Cayetano HerediaJuan Miguel Pascale, Principal investigator, Instituto Conmemorativo Gorgas de Estudios de la SaludJaime Soto, Principal investigator, Fundación Nacional de DermatologíaGlaucia Cota, Principal investigator, Instituto René Rachou Oswaldo Cruz Foundation- FIOCRUZ MINAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515186
- Sponsor's protocol ID
- DNDi-MILT-08-CL
- Status last verified
- Feb 2024
- First submitted
- 13 Aug 2020
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Thermotherapy in Combination With Miltefosine Compared Iltefosine Monotherapy for the Treatment of New World Cutaneous Leishmaniasis: A Phase III, Open Label, Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT04515186
- Acronym / sponsor ID
- DNDi-MILT-08-CL
- Conditions
- Cutaneous Leishmaniases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates if the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine is safe and have a comparable cure rate with the current recommended first line treatments comprising meglumine antimoniate for 3 weeks for the treatment of uncomplicated cutaneous leishmaniasis cases in the New World.
Detailed description
This randomized, open label, multi-centre, non-inferiority study aims to compare that the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine (2.5 mg/kg/day for 21 days orally) (here after referred to as combination), is non-inferior to the current recommended first line treatment miltefosine monotherapy (2.5 mg/kg/day for 28 days orally), for uncomplicated CL cases in the New World.
Originally, the study was planned to assess the non-inferiority of the combination therapy in comparison to the current recommended first line treatments, meglumine antimoniate or miltefosine monotherapy for 28 days. However, based on the revised treatment guidelines published by WHO-PAHO in 2022 in which the use of systemic antimonial received only a conditional recommendation, principally because of its well-known toxicity, and is recommended to be used only in case where there is no other option, the study protocol amendment 7 was proposed to prematurely discontinue the inclusion of additional patients in the meglumine antimoniate arm.
Primary Objective
- To determine the non-inferior efficacy of the combination in comparison to the standard first line treatment miltefosine monotherapy as measured by the percentage of patients with initial clinical cure at Day 90.
Secondary objectives
- Assess the proportion of patients who show clinical improvement at D90 (have more or equal of 75% and less than 100% re-epithelization) and achieve 100% re-epithelization at D105 (late responders).
- Assess the proportion of relapses at D180.
- Describe the proportion of patients randomized in the meglumine antimoniate arm until its discontinuation who show initial cure at D90, clinical improvement at D90 and 100% re-epithelization at D105 and relapse at D180.
- Assess the safety and tolerability profile for each regimen (percentage of treatment discontinuation, frequency and severity, causality with each study drug and seriousness of Adverse Events (AEs)).
- Assess the time to achieve 100% re-epithelialization/ flattening of ulcerated/ non ulcerated lesions by Leishmania species.
A computer-generated randomization code will be used for patient treatment allocation to one of the three arms indicated and utilizing a 1:1:1 allocation ratio.
Patients assigned to the combination treatment will start treatment at Day 1 and have a follow-up visit on 24 hours to assess safety of thermotherapy. Hereafter, these patients are required to return at Days 7, 14, 21, 45, 63, 90, 105 (late responders only) and 180 after the beginning of treatment to assess safety and efficacy.In Brazil, women of childbearing potential are required to also return on D120 and D150 to perform blood pregnancy tests. Women with irregular menstrual cycle, should return for blood pregnancy tests every two weeks until D150.
Patients assigned to the meglumine antimoniate treatment before discontinuation of this arm becomes effective arerequired to come at Days 1, 7, 14, 21, 45, 63, 90, 105 (late responders only) and 180 after the beginning of treatment to assess safety and efficacy.
Patients assigned to the miltefosine monotherapy are required to come at Days 1, 7, 14, 21, 28, 45, 63, 90, 105 (late responders only) and 180 after the beginning of treatment to assess safety and efficacy. In Brazil, women of childbearing potential are required to also return on D120 and D150 to perform blood pregnancy tests. Women with irregular menstrual cycle, should return for blood pregnancy tests every two weeks until D150.
Patients who have 100% re-epithelization at D90 are declared cured and appointed to come to their D180 assessment. If at D90 re-epithelization of the ulcer(s) is more or equal to 75% but less than 100%, patients will be defined as having clinical improvement and will be asked to return to D105 for a late responder assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meglumine Antimoniate | Other | Drug: Meglumine AntimoniateMeglumine Antimoniate, 20 mg/kg/day for 20 days parenterally. This trial arm was discontinued after protocol amendment 7. However, patients assigned to this arm before protocol amendment 7 becomes effective will continue in the study and will receive complete treatment as initially planned. |
| Miltefosine monotherapy | Active comparator | Drug: MiltefosineMiltefosine monotherapy 2.5 mg/kg/day for 28 days orally |
| Thermotherapy + miltefosine | Experimental | Drug: Miltefosine, Device: Thermotherapy machineThermotherapy (one session, 50⁰C for 30" applications*) + miltefosine 2.5 mg/kg/day for 21 days orally. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Males and females, aged ≥12 and ≤60 years old (upper age limit according to local regulations), and weighing ≥ 30Kg.
- Patient with a confirmed diagnosis of CL in at least one lesion by at least one of the following methods: 1) microscopic identification of amastigotes in stained lesion tissue, or 2) demonstration of Leishmania by Polymerase Chain Reaction (PCR), or 3) positive culture for promastigotes.
- Patient has a lesion that satisfies the following criteria:
- Patient able to give written informed consent/ assent form.
- In the opinion of the investigator, the patient is capable of understanding and complying with the protocol.
Key exclusion criteria (12 listed)
- Female with a positive urine or blood pregnancy test at screening or who is breast feeding or female at fertile age who does not agree to take appropriate effective contraception during treatment period and up to D180 visit. In Brazil: female at fertile age who does not agree to use two effective methods of contraception: one barrier method and one highly effective method (defined in section 8.2.4) 30 days prior to the treatment onset and up to D180 visit.
- History of clinically significant medical problems / treatment that might interact, either negatively or positively, with treatment of cutaneous leishmaniasis including any immunocompromising condition.
- Within 8 weeks (56 days) of Day 1, received treatment for the entry lesion leishmaniasis with any medication including antimonials likely, in the opinion of the PI, to modify the course of the Leishmania infection.
- Has diagnosis or suspected diagnosis of mucocutaneous leishmaniasis based on physical exam.
- Has laboratory values at screening as follows:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meglumine AntimoniateAlso: Glucantime®Vials of a 5mL solution. Each vial contains 405 mg of Sb5+ corresponding to 8.1% Sb5+ (81 mg/mL). | Drug | Meglumine Antimoniate |
| MiltefosineAlso: Impavido®50 mg capsule | Drug | Miltefosine monotherapy, Thermotherapy + miltefosine |
| Thermotherapy machineAlso: ThermoMed™Localized Current Field radio-frequency generating device | Device | Thermotherapy + miltefosine |
Primary outcome
The proportion of initial clinical cure in each arm.
Time frame: Day 90
Defined for ulcerated lesions as 100% re-epithelialization of the ulcer(s) on D90 as compared to D1 and for non-ulcerated lesions as flattening and/or no signs of induration of the lesion(s) on D90 as compared to D1.
5 secondary outcomes
The number of patients who fulfil the criteria for clinical improvement at D90 and late responders at D105.
Time frame: Days 90 and 105
The number of patients who fulfil the criteria of initial cure at D90 or late responders at D105 and have no relapse by D180 (final cure).
Time frame: Day 180
Percentage of treatment discontinuation, frequency, severity, causality with each study drug and seriousness of AEs by treatment group.
Time frame: Through study completion, i.e up to 6 months
Proportion of lesions with 100% re-epithelialization/flattening at each measurement time point by Leishmania sp.
Time frame: Days 7, 14 and 21. At end of treatment (days 21 or 28), and at days 45, 63, 90, 105 and 180.
The number of patients randomized in the meglumine antimoniate arm until its discontinuation who fulfill the criteria of initial cure at D90 or late responders at D105 and have no relapse by D180 (final cure).
Time frame: Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo Machado principal investigator
Federal University of Bahia
Marcia Hueb principal investigator
Julio Muller University Hospital Federal University of Mato Grosso
Fiorela Yuly Alvarez Romero principal investigator
Universidad Peruana Cayetano Heredia
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meglumine Antimoniate, Miltefosine and Thermotherapy machine in people with Cutaneous Leishmaniases, run by Drugs for Neglected Diseases at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil, Bolivia, Panama, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of initial clinical cure in each arm. (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.